Events

Device Recall Hydrophylic guidewire 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Merit Medical Systems, Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    56161
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2104-2010
  • 사례 시작날짜
    2010-06-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-10-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92768
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    wire, guide, catheter - Product Code DQX
  • 원인
    Guidewires have decreased lubricity at the proximal end, inhibiting proper operation.
  • 조치
    The firm, Merit Medical System, Inc., notified the Sales representatives by e-mail on June 28, 2010, and instructed them to contact all of their accounts and to advise them to discontinue use and return any unused products to Merit. A Product Recall Notice was to be completed by each facility under the direction of the rep and all activities were to be completed by July 9, 2010. Questions should be directed to Penny Goldman, Senior Product Manager at 801-208-4198 or Jackie Preece, Manager, Customer Service at 801-208-4365.

Device

Device Recall Hydrophylic guidewire
  • 모델명 / 제조번호(시리얼번호)
    Lot Number K130761 (3 year expiry), P116003 (1 year expiry)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: CA, CO, FL, GA, IL, IN, KS, MA, MD, MI, MN, NC, NH, NJ, NY, PA, and SD.
  • 제품 설명
    Merit Laureate Hydrophylic Guide Wire, Angled, Made In Ireland, CAT No: LWSTDA35260EX, 260cm, Sterile EO, Merit Medical Systems, Inc., South Jordan, UT 84095. || Intended to facilitate the placement of devices during diagnostic and interventional procedures.
  • Manufacturer
    Merit Medical Systems, Inc.

Manufacturer

Merit Medical Systems, Inc.
  • 제조사 주소
    Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan UT 84095
  • 제조사 모회사 (2017)
    Merit Medical Systems Inc
  • Source
    USFDA